NCT05032690

Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule

A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, 4-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY TO COMPARE THE BIOAVAILABILITY OF ORALLY ADMINISTERED BOSUTINIB CAPSULES AND TO ESTIMATE THE EFFECT OF FOOD ON BOSUTINIB CAPSULE

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules relative to four 25 mg capsules under fed condition in adult healthy participants and to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a single 100 mg capsule of bosutinib relative to fasted condition in adults healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extend of absorption (Cmax, AUC). Statistical analyses will be performed after the administration of a single 100 mg dose under fed condition as the Reference treatment and the four 25 mg capsules as the Test treatment for the first comparison, and after administration of a single 100 mg dose under fasted condition as the Reference treatment and the 100 mg capsule under fed condition as the Test treatment for the second comparison.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Bosutinib capsule	Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast
DRUG	Bosutinib capsule	Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast
DRUG	Bosutinib	Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours
DRUG	Bosutinib capsule	Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast

Timeline

• Start date: 2022-01-19
• Primary completion: 2022-06-25
• Completion: 2022-06-25
• First posted: 2021-09-02
• Last updated: 2024-09-20
• Results posted: 2024-09-20

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study